US4846181A - Soft tissue wound healing therapy utilizing pulsed electrical stimulation - Google Patents
Soft tissue wound healing therapy utilizing pulsed electrical stimulation Download PDFInfo
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- US4846181A US4846181A US07/103,696 US10369687A US4846181A US 4846181 A US4846181 A US 4846181A US 10369687 A US10369687 A US 10369687A US 4846181 A US4846181 A US 4846181A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/326—Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells
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- This invention relates to wound healing therapy and, more particularly, relates to soft tissue wound healing therapy utilizing pulsed electrical stimulation.
- application of electrical stimulation can promote wound healing; that electrical stimulation can be applied to a wound through electrodes in the presence of saline; that low intensity direct current (LIDC) can be utilized as the applied electrical stimulation; that low intensity direct current (LIDC) can be initially applied as negative current through an active electrode adjacent to the wound; that applied LIDC stimulation can be switched between negative and positive polarities during the course of treatment; that pulses might be applied as the electrical stimulation for achieving wound healing; that high voltage, low amperage galvanic stimulation can be applied to a patient; that high voltage, low amperage galvanic stimulation can be applied to a patient initially through a cathode and later through an anode at the wound; and that high voltage, low amperage galvanic stimulation can be applied for short treatment pulses that are periodically repeated.
- LIDC low intensity direct current
- LIDC low intensity direct current
- the above-listed patents include a showing: that electrical stimulation can be effected at preselected low intensities; that preselected treatment times between a few minutes to a few hours can be utilized; that the polarity of the active electrode can be switched during the course of treatment; and that pulses can be utilized as electrical stimulation.
- This invention provides an improved process for enhancing, including promoting and/or accelerating, soft tissue wound healing utilizing pulsed electrical stimulation.
- the process of this invention includes application of repeated short treatments of high intensity, substantially rectangular, electrical pulses applied to a soft tissue wound through an active electrode positioned at the wound, and with the dispersive electrode being positioned at a distance from the wound.
- the active electrode positioned at the wound is normally caused to provide negative pulses to the wound during a first treatment period of a treatment cycle, and then later is caused to provide positive pulses to the wound during a second treatment period of the treatment cycle, with the treatment cycle being thereafter preferably repeated one or more times in treating most soft tissue wounds.
- the negative pulses cause debriding of the wound, as well as being useful to reduce edema.
- FIG. 1 is a sketch illustrating, typically, electrode positioning for direct pad application of pulsed electrical stimulation from a stimulation unit
- FIG. 2 is a sketch illustrating, typically, electrode positioning for hydrotherapy application of a pulsed electrical stimulator from a stimulation unit;
- FIGS. 3A and 3B are typical waveforms deliverable through the active electrode to a wound
- FIG. 4 is a typical representation of a treatment cycle
- FIGS. 5, 6A, 6B, 6C and 6D are graphs illustrated particular results achieved during pig studies
- FIG. 7 is a graph illustrating glucose and lactate distribution with bipedicle skin flaps on day one post-operatively.
- FIG. 8 is a graph illustrating particular results achieved using the now preferred protocols of this invention.
- Effective enhancement, including promotion and acceleration, of wound healing is accomplished by this invention utilizing pulsed electrical stimulation.
- pulses delivered from an electrical stimulation unit 11, are preferably applied to a soft tissue wound (indicated generally by the numeral 13) on a body 15 through an active electrode 17 positioned at the wound.
- a soft tissue wound indicated generally by the numeral 13
- Such application can be effected by direct pad application, as indicated in FIG. 1, or can be effected by hydrotherapy, as indicated in FIG. 2, with the pulses being delivered to the wound through active electrode 17 immersed in a saline solution 19.
- a dispersive, or return, electrode 21 is positioned in contact with the body of the patient being treated, with the dispersive electrode being preferably positioned at a distance from the wound, as is indicated in FIGS. 1 and 2. It has been found that at least for some phases of treatment, edema reduction being an example, the dispersive electrode should be as far from the active electrode as possible.
- Electrical stimulation unit 11 preferably provides high intensity pulses that are applied through the active electrode to the wound being treated.
- a unit for providing such pulses is a pulsed galvanic electrical stimulator unit commercially offered for sale by Staodynamics, Inc., the assignee of this invention, and is known as a STAODYN Vara/Pulse Stimulator that has heretofore been shown to be useful for treating conditions such as inflammation, edema, sprain, and muscle spasm (STAODYN is a registered trademark of Staodynamics, Inc.).
- the pulse rate of the unit can normally vary about ⁇ 2%, while the pulse can normally vary about ⁇ 10 ⁇ sec.
- the unit can cause delivery of negative or positive pulses from the active electrode with a constant current intensity of between 0 to 100 milliamperes (ma).
- the current intensity of delivered pulses when referred to in milliamperes, means milliamperes peak. It has also been found that the STAODYN Vara/Pulse unit normally provides a voltage across a patient of between about 10 to 30 volts peak.
- FIG. 4 indicates a typical cycle of soft tissue wound treatment.
- Multiple pulses of a predetermined polarity are preferably first applied through the active electrode to a soft tissue wound during first short treatment intervals of a first treatment period of a treatment cycle, after which the polarity of the pulses applied through the active electrodes is reversed (to positive pulses as indicated in FIG. 4) during second short treatment intervals of a second treatment period of the treatment cycle.
- the pulses applied through the active electrode during the first (or initial) intervals of the first treatment period are preferably negative pulses which are repeatedly applied for one or more days, after which positive pulses are applied through the active electrode during the second intervals of the second treatment period to thus complete a treatment cycle that commonly extends for a number of days. The cycle is then normally repeated until healing is completed.
- a short treatment period of between about 15 to 45 minutes (with a 30 minute treatment period being now preferred), applying pulses to the active electrode having an intensity of between about 2.8 to 7.0 ⁇ coulombs per pulse (with about 5 ⁇ coulombs per pulse intensity being now preferred) using constant current pulses having an intensity of about 20 to 50 ma (with constant current pulses of about 35 ma being now preferred), at a rate of between about 32 and 128 pulses per second (with rates of 128 pps and 64 pps being now preferred), with the treatment being applied between about 2 to 4 times a day (with a treatment of two times a day being now preferred), and with the applied pulses being alternated between about each 1 to 3 days (depending upon the particular protocol utilized) has been effective in enhancing wound healing and, particularly, in enhancing healing of chronic wounds.
- the initial therapy treatment utilized included: application of negative pulses, positive pulses, and alternating negative and positive pulses, at rates between 8 and 128 pps, and at intensities between 20 ma and 100 ma; a treatment time of 2 hours on, 2 hours off continuously, 2 hours on, 2 hours off for 8 hours, and decreasing of treatment time by increments of 15 minutes from 2 hours to 15 minutes until reaching a treatment time of 30 minutes twice daily with not less than 4 hours between treatments (which was initially selected as the best therapeutic treatment time for future development); treatment with pad placement (sponge) directly into the wound, directly over a saline soaked 4 ⁇ 4 gauze, into the wound directly over semi-occlusive dressings, or directly over a saline dressing; treatment with an immersible electrode (used only in a continuous mode at a rate 128 pps with pads negative and positive and at an intensity 30-50 ma); use of a dispersive pad placed on the anterior and posterior body trunk, anterior and posterior thigh, buttocks, abdomen area, the shoulders (high), upper and
- wound hemorrhaging and perimeter deterioration at intensities above 50 ma with some improvement being noted in the character of the wound, and with no change noted in wounds treated at 20 ma; wounds treated in an interrupted mode showed improvement at intensities above 50 ma, but skin irritation around the wound occurred; and in spite of varied parameters, treated wounds generally showed some improvements either in measurements or character.
- a 60 pound domestic pig was lightly anesthetized and four eight centimeter diameter wounds were made on the animal's side. This wound was made down to the muscular fascia and the tissue removed. Dry sterile dressings were placed on each wound. Starting the following day, electrical stimulation to three of the four wounds was performed for one-half hour, twice a day separated by a four hour interval, with the experiment was continued for three weeks.
- a STAODYN Vara/Pulse stimulator unit was used for providing pulsed stimulation with the negative pad on the wounds and with the intensity of applied pulses being at levels felt from past clinical experience to be low, preferred, and high (15 ma, 35 ma, and 50 ma, respectively).
- a summary of the stimulation settings is set forth in Table II, and resulting wound surface areas are set forth in Table III.
- Planimetry data showed little effect of stimulation at 15 ma. However, a marked improvement was seen with stimulation at 35 ma, and 50 ma stimulation did not seem to be as beneficial as stimulation as stimulation at 35 ma. The foregoing, however needed to be confirmed in additional animals to thereby establish a dose-response curve to help show the efficacy of electrical stimulation in augmentating the healing of soft tissue wounds.
- Phase One study appeared to show a favorable effect on wound healing with negative current stimulation in one animal, Phase Two studies were designed to further evaluate an ideal protocol to be used.
- an electrical stimulation protocol was begun (as described hereafter). At weekly intervals the wounds were evaluated by taking a standard photograph for standardized computer assisted planimetry. The protocol was continued for four weeks.
- Phase-Two stimulation settings are set forth in Table IV, and resulting wound surface areas are set forth in Tables V, VI, and VII.
- FIG. 5 illustrates by graph the results obtained during the Phase II study.
- the postulate of the second phase of this animal study was that the electrical stimulation of the open, acute wound could be helpful in the healing of the wound.
- the protocol was designed to assess wound surface area changes during various types of stimulation (i.e., negative stimulation, and negative stimulation alternating with positive stimulation). Six animals were utilized for this study and a significant amount of information was obtained.
- the experimental animal was clipped with standard animal clippers. The skin on the back and both sides of the animal was prepared for wounding by washing with a nonantibiotic soap. On the day of wounding (Day 0), the animal was anesthetized with ketamine 1.7 mg/kg intramuscular and inhalation of halothane, oxygen and nitrous oxide combination.
- Vara/Pulse Stimulator units Six STAODYN Vara/Pulse Stimulator units were used to treat the experimental animals. Three units (1-A,B,C) produced pulsed electrical current and the other three units (2-A,B,C) served as a sham control.
- Treatment pads 3" ⁇ 3" were saturated with sterile normal saline in sterile petri dishes and secured to each animal's body with velcro straps. At least two inches of non-wounded skin separated each treatment area. A large dispersive pad was saturated with tap water and placed on the ventral thoracic area of the animal. All pads were plugged into an associated STAODYN Vara/Pulse unit.
- the experimental animal was placed in a "pig sling" during the two 30 minute daily treatment.
- the "pig sling” is a canvas hammock which is attached to a steel frame and has lamb's wool padded openings for the legs of the animal.
- the number of wounds healed (re-epithelized) per day was divided by the total number of wounds sampled and multiplied by 100, as shown in Table VIII.
- the percentage of wounds healed was then plotted against the days after wounding. A curve was constructed from the data and the time needed for 50% of the wounds to heal was determined, and is shown in FIG. 6A.
- Wounds were evaluated according to the methods described in Experiment 1. The HT 50 and relative rate of healing were determined and compared to the sham treated animal in Experiment 1. Wounds treated with machines 1-A,B,C, were 100% re-epithelized on day 4 after wounding whereas the sham treated wounds had only initiated re-epithelization on day 6 after wounding. The results are presented in Tables X and XI and in FIG. 6B.
- the number of wounds re-epithelized per day was divided by the number of wounds sampled and multiplied by 100 as set forth in Table XII.
- the percentage of wounds healed was then plotted against days after wounding. A curve was constructed from the data and the time needed for 50% of the wounds to heal was determined as shown in FIG. 6C.
- the HT 50 and relative rate of healing were determined and the active machine treated wounds were compared to sham treated wounds as set forth in Table XIII.
- the percentage of wounds healed was plotted against days after wounding as shown in FIG. 6D.
- the HT 50 or time required for 50% of the wounds to heal was calculated for each treatment using logistics regression analysis and the relative rates of healing were determined for each treatment and is set forth in Table XV.
- the skin flaps were created by means of parallel incisions, with undermining in the superficial fascial plane beneath the panniculus carnosus, preserving dorsal and ventral pedicles.
- the flaps were sutured into position in their donor sites.
- the ventral pedicles were situated 4 cm from the nipple line, and the dorsal pedicles were situated 3-4 cm from the dosal midline.
- the flaps were separated from each other by a distance of 6 cm.
- the animals were placed in a body sling during electrotherapy.
- the most ischemic area of the flaps was identified on the basis of tissue glucose and lactate as being 9-13 cm from the ventral pedicle, as shown by FIG. 7.
- the ischemic areas of the flaps were treated with electrical current using a STAODYN Vara/Pulse stimulation unit.
- Control animals received either a sham treatment (2 pigs) or no treatment (3 pigs).
- the experimental group (7 pigs) was treated with negative electrical current for 30 minutes twice daily during the initial 3 days, with positive electrical current during days 4-6, and with negative electrical current during days 7-9.
- the intensity of the electrical current was 35 milliamperes at a frequency of 128 Hz.
- Skin biopsies were obtained under anesthesia from the ischemic central portions of the bipedicle flaps on days 3, 6, and 14 following flap elevation.
- the skin samples were frozen immediately in liquid nitrogen and sectioned (20 um in thickness) vertical to the skin surface in a cryostat (-25° C.).
- the tissue sections were dried overnight under a vacuum in the frozen state.
- the lyophilized sections were stored in a vacuum tube at -20° C. until biochemical assays were performed.
- Full-thickness skin (excluding the panniculus adiposus and panniculus carnosus) were microdissected and weighed (approximately 0.1 mg) on a torsion balance.
- Tissue glucose, lactate, and ATP were measured by enzymatic fluorometric methods.
- RNA/DNA ratios were determined by fluorometric methods, and malondialdehyde (MDA) levels were determined by the thiobarbutric acid methods.
- Table XVII summarizes the results of biochemical arrays of tissue metabolites in the central portions of the bipedicle flaps.
- the control flaps exhibited a decrease in glucose and ATP content and an increase in lactate and MDA levels on day 3 postoperatively.
- the flaps treated with negative electrical current during the initial 3 days demonstated higher glucose and lower lactate levels as compared with the control flaps.
- the ratio of lactate to glucose was considerably higher in the flaps than in normal skin.
- the treated flaps demonstrated a lower lactate/glucose ratio than the control flaps.
- ATP content was 24% of normal in both the control and treated flaps.
- MDA levels were 3.6 times normal in the control and 2.4 times normal in the treated flaps on day 3. In general, there was no significant difference in the levels of metabolites in the control and treated flaps on days 6 and 14. Tissue glucose returned to normal by day 6.
- Lactate decreased gradually toward normal following the maximal increase observed on day 3. Lactate/glucose ratios were improved considerably on days 6 and 14. The treated flaps appeared to contain greater ATP content than the control flaps on day 6, but ATP content returned to normal in all flaps by day 14. Flap tissues maintained higher MDA levels during the initial 6 days following operation. No significant alterations of nucleic acid content were found in flap tissues recovering from ischemia.
- a large dispersive pad is saturated with tap water and placed on a large muscle group a minimum of 12 inches from the treatment area and secured to the patient with velcro belts so that the pad makes good body contact; the extremity to be treated is placed into a small plastic container tall enough to cover all lesion areas and the container is filled with isotonic saline; one or two small silicone immersible electrode pads (if the lesion area is greater than 25 square centimeters (5 cm ⁇ 5 cm) two silicone immersible pads are used and these pads should be within 10 cm of the lesion area) are placed into the saline in the plastic container immediately adjacent to the lesions (if the lesions are in the mid-leg area, the electrodes may be secured loosely using the velcro pads); the electrodes are then connected to the STAODYN Vara/Pulse unit with the large dispersive pad being connected to the return jack of the unit; and the STAODYN Vara/Pulse controls are set
- Treatment is effected for 30 minutes twice daily, with a minimum of four hours, and a maximum of 8 hours, between treatments.
- the parameters set forth are maintained until the wounds exhibit a serosaguineous drainage without a yellow exudate, at which time the intensity is adjusted to 30 ma, after which the pads are made negative ⁇ 1 day and then made positive ⁇ 1 day to full wound closure.
- small treatment pads and a large dispersive pad are utilized.
- the large dispersive pad is saturated with tap water as described above, and the small treatment pads are saturated with normal saline.
- a 4 ⁇ 4 gauze dressing which has been wet with normal saline is placed directly over and covering the area to be treated, and the small treatment pads are placed over the gauze dressing, after which all pads are secured to the patient's body with velcro straps.
- the small treatment pads are then plugged into the STAODYN Vara/Pulse unit, and the large dispersive pad is plugged into the return jack of the STAODYN Vara/Pulse unit.
- Treatment is effected for 30 minutes twice daily, with a minimum of four hours, and a maximum of 8 hours, between treatments.
- the above parameters are maintained until the wound exhibit a serosaguineous drainage without a yellow exudate, after which the intensity is adjusted to 30 ma and the pads are made negative ⁇ 1 day, and then made positive ⁇ 1 day to full wound closure.
- Treatment is effected for 30 minutes twice daily, with a minimum of four hours, and a maximum of 8 hours, between treatments.
- the parameters set forth are maintained until the wound has been debrided and is "clean" or a serosaguineous drainage appears, at which time the pads are made negative ⁇ 3 days, and then made positive ⁇ 3 days until the wound reaches a Stage II classification, at which time the pulse rate is switched to 64 pps and the pad polarity alternated each day until the wound is completely healed.
- Treatment is effected for 30 minutes twice daily, with a minimum of four hours, and a maximum of 8 hours, between treatments.
- the rate is reduced to 64 pps and the intensity to 35 ma, and the pad polarity is alternated daily.
- the burn area is observed prior to each treatment for evidence of epithelization or skin buds. When this occurs, the treatment pads are maintained positive until full closure of the wound.
- Treatment is effected for 30 minutes twice daily, with a minimum of four hours, and a maximum of 8 hours, between treatments.
- the above settings are maintained until the eschar is removed and the wound is red and beefy in appearance, after which the pad current polarity is switched to a rate of 64 pps and an intensity of 25 ma until full closure of the wound occurs.
- the pads are prepared in the same way as described above.
- a sterile 4 ⁇ 4 gauze pad that is wet with saline, is placed over the graft site, and the treatment pad, saturated with saline, is placed over the 4 ⁇ 4 gauze pad.
- the pads are prepared in the same way as described above.
- a sterile 4 ⁇ 4 gauze pad that is wet with saline, is placed over the donor site, and the treatment pad, saturated with saline, is placed over the 4 ⁇ 4 gauze pad.
- Pad polarity is made negative for 1 day, then switched to positive polarity until the site is healed.
- the first 67 entries have acceptable data (the remaining 30 entries have data that could not be analyzed for a variety of reasons). Analysis of data for the first listed 67 entries is set forth in Table XIX (by categories of wounds treated), and Table XX (all wounds analyzed).
- sham patients had about 27% of their wounds healed at the end of four weeks, while stimulated patients has about 43% of their wounds healed at the end of four weeks of treatment.
- each predetermined period (such as each day or period of days) can produce continued healing of a deep wound, while continuous use of one polarity of pulses might not sustain wound healing (and might even eventually make the wound larger).
- the current density over the wound is constant and the nerve stimulation potential remains constant. This means that toward completion of healing, newly healed tissue at the margin of the wound is treated along with the wound.
- Negative current also tends to liquify crust and thereby strip off blood clots and cause bleeding, while positive current can be used to control bleeding after a surgical debridement. Both are important in wound healing.
Abstract
Description
______________________________________ Patent Number Inventor Issue Date ______________________________________ 2,099,511 Caesar November 16, 1937 3,918,459 Horn November 11, 1975 3,964,477 Ellis et al June 22, 1976 4,019,510 Ellis April 26, 1977 4,233,965 Fairbanks November 18, 1980 4,312,340 Donadelli January 26, 1982 4,313,438 Greatbatch February 2, 1982 4,314,554 Greatbatch February 9, 1982 4,556,051 Maurer December 3, 1985 ______________________________________
TABLE I ______________________________________ Patient Type No. Wound Rate Intensity Current Mode ______________________________________ 1A Pilonidal 128 20-40 Continuous 1B Cysts 128 20-40 Continuous 1C 64 35-45 Continuous 2 Decubitus 128 50-80 Continuous Ulcer 3A Burns 128 30-50 Continuous 3B 128 50-80 Continuous 4A Malignant 128 25 Continuous 4B Lesions 128 30 Continuous 4C 128 25 Continuous 4D 128 25-30 Continuous 5A Decubitus 128 30-60 Continuous Ulcer 6A Sacral 128 35-45 Continuous 6B Decubitus 128 30-40 Continuous 6C Ulcers 64 30-40 Continuous 7A Burn 14 32 30-52 Continuous 7B Sacral 64 40-80 Continuous Decubitus Ulcer 8A Decubitus 128 60 Interrupted Ulcers Later Changed to continuous 8B 8 50 Continuous 8C 40-50 8D 32 40-60 Continuous 8E 128 60 Continuous 8F 64 80 Continuous 8G 128 30 Continuous 9A Abscesses 128 80-100 Continuous 9B 50-60 Continuous 9C 32 50-60 Continuous 9D 32 80-100 Continuous 9E 32 80-100 Continuous 9F 128 80-100 Continuous 9G 8 50-60 Continuous 9H 128 80-100 Continuous 9I 8 50-60 Continuous 9J 32 50-60 Continuous 9K 128 50-60 Continuous 10A Pemphignoid 8 58 Interrupted 10B Lesions 28 80-100 Continuous 10C 8-32 40-50 Continuous 11A Decubitus 8-32 30-50 Continuous 11B Ulcers 64 40-80 Continuous 12A Decubitus 32 50-60 Continuous 12B Ulcers 128 80-100 Continuous 13A Bilateral 128 30-50 Continuous 13B Vascular 32 45 Continuous Lesions ______________________________________ Pat. Pad Selection No. & Placement Effects ______________________________________ 1A Water Immersible Electrode Good red tissue, inserted with saline granulation of tunnel gauze into sinus tract to wound base. anal.) Neg × 3 days × 30 min 1B Pos × 3 days × 30 min 1C Neg × 3 days × 30 min Wound healed in 3 Pos × 3 days × 30 min months. Dispersive pad onabdomen 2 Negative current only. Wound debrided and Used 3 devices with began to granulate so electrodes dropped in that skin grafts hubbard tank. Disper- become possible. sive pads × 3 on shoulders and back, wet dressing between treatments. 3A Negative-direct pads Contractures made this into wounds. ineffective - no improvement. Some skin irritation. 3B Immersible electrodes Evidence of healing in hubbard tank. without rigid scarring. Took a minimum of 4 months. 4A Dispersive pad: thigh treatment pads into leg lesions. Negative 30 min. twice a day × 5 days. 4B Positive, 30 min, twice Could not tolerate a day × 3 days direct pad - increased pain during positive. 4C Dispersive pad - shoulder Tolerated 25 intensity due to edema decrease in for several days. legs. 4D Negative only - direct Then straight pad. negative. Wounds did not heal but edema was reduced and pain decreased. 5A Dispersive pad: back and Heavy margin then thigh. fused eschar covering sacral decubitus.Negative polarity 30 Developed generalized min., twice a day × septicemia within 3 7 days or until wound days of treatment. debrided. Determined that opening must be made into eschar prior to treatment, however eschar became soft - but no opening for drainage. 6A Neg × 3 days × 45 min Severe burn around twice a day wound - severe drying of wound bed - Pos × 3 days × 45 min deterioration. twice a day This happened in 4 Use betadine dressing days. Treatment held between treatments. × one week, then changed dressing. 6B Neg × 3 days × 30 min Wound showed im- twice a day provement, but began Pos × 3 days × 30 min to deteriorate at twice a day wound edges. Saline dressings between treatments. Dispersive pad abdomen and thigh rotation. Treatment pads into wounds. 6C Pos twice a day × 3 days Wound healed. × 30 min Neg twice a day × 3 days × 30 min 7A Neg × 3 days (in wound) Some volume Dispersive pad - shoulder reduction of ulcer and back. noted. Improvements in wound size and 7B Pos × 3 days (in wound). character. Severe skin irritation results of E-stim and Betadine noted. Wound hemorrhage caused by negative current forced stop to treatment for 1 week. Errythemia noted peri-wound, very sensitive to touch. Wounds begin to break down around edges. Fungus infection on buttocks at electrode sites. E-stim produced hypertrophic skin in portions of ulcer. Severe skin irritation under all electrodes from stimulation re- quiring topical meds, treatment ended. 8A Pos × 3 days (in wound) Betadine soaks Dispersive pad discontinued prior to E-stim. Area size of ulcer smaller but increase purulent drainage. Hydrogen peroxide irrigation before each E-stim treatment. Continued improvement. 8B Neg × 3 days (in wound) Developed rash 4-5 days initially, peri-wound. or until wound is Tried positive clean. current only × 14 days no improvement - extremely slow healing. 8C Purulent draining in- creased. 8D Negative 8E Pos × 3 days, then Good granulation alternate with neg. noted. 8F Began alternating Wound progression polarities for 3 days, ceased. Back to neg twice a day × 30 min. current, wound cleaned up in 14 days. 8G Pos twice a day × 30 min Began flushing wound Neg Alternate every 3 days with normal saline prior to treatment and changing moist dressing once a day. Treatment stopped × 10 days due to wound deterioration and purulent drainage. Treatment discontinued. 9A Pos × 2 hours twice Complaints of pain a day × 3 days under all pads. 9B Neg × 2 hours twice Ulcer responding to a day × 3 days treatment while in neg current. 9C Neg × 2 hours twice P.0. antibiotics a day to alternate ordered for general every 3 days with infection. Developed positive current ×monilial infection 2 hours, twice a day under dispersive pad for 3 days. Dispersive and peri-wound. Treat- pad: back. Treatment ment stopped. pads in wound. 9D Positive × 15 minutes Wound worsened. Did not place pads in wound - but on each 9E Neg × 7 days × 45 min side, then above then pos × 15 min. wound. 9F Pos × 30 min twice a Elase ointment for day alternate every debriding. three days, then alternate. 9G Same schedule every No change in wound other day. size. 9H Pos × 30 min in a.m. Wound treatment 9I Neg × 30 min in p.m. discontinued - 9J Neg every other day × didn 'T heal. 5 days Skin continued to be 9K Pos every other day × irritated.Complaints 5 days. of pain throughout E-stim treatment. 10A Alternating pads neg Some improvement × 2 hours twice a day noted in wound (4 hours off) × 3 days character then off × 3 days. (drainage, no pain). Dispersive pad place- Used duoderm dressing. ment rotation every day. Treatment continued Treatment pads in wounds. due to decreased Saline used as conductor. lesion progression. 10B Pos × 3 days twice a day Treatment dis- (2 hours on, 4 hours off) continued due to Neg × 3 days twice a day wound hemorrhage caused by negative (2 nours on, 4 hours off) current intensity. Developed abdominal Dispersive pad: shoulders. dermatitis region of wounds. Used wet dressings between treatments. Complaints of pain until end of treatment. 11A Neg twice a day × 30 Some improvement minutes × 3 days noted for 2 weeks. alternate with pos Decubitus worsened - twice a day × 30 minutes treatment dis- × 3 days. continued. 11B Dispersive pad, rotate shoulders. Treat- ment pads in wound. Moist dressings on wounds.12A Neg 30 minutes twice a Evidence of day, alternate every granulation. three days. 12B Pos: 30 minutes twice a Healed. day, alternate every 3 days. 13A Neg × 1 hour twice a day Took 2 months for until wounds are debrided wounds to debride - of eschar, dispersive pad these were large on abdomen. Water treat- wounds. Skin buds ment pad in plastic bucket noted in wound and of normal saline (1 tsp later increased skin per quart). bud production noted. 13B Neg alternating with Wounds continued to pos × 30 minutes every improve and healed. day. ______________________________________
TABLE II ______________________________________ (Phase 1) NEGATIVE PAD ONWOUND ______________________________________ # 1Control # 2 Too Low 128pps Intensity 15ma # 3 128 pps Intensity 35ma # 4 Too High 128pps Intensity 50 ma (Just below fasciculations) 1/2 hour, 2/day Dispersive Electrode at Least 12 inches away from activeelectrode ______________________________________ # 1Left back # 2Left front # 3Right back # 4 Right front
TABLE III ______________________________________ (Phase One) WOUND SURFACE AREA (cms.sup.2) Zero One Two Three Wound Time Week Weeks Weeks ______________________________________ No stim. 27.29 37.65 30.21 19.00 Low Stim. 25.53 25.06 20.64 Preferred Stim. 36.66 34.01 29.81 9.20 High Stim 29.64 28.53 15.90 ______________________________________ Low Stim. is 15 ma at 128 pps Preferred Stim. is 35 ma at 128 pps High Stim is 50 ma at 128 pps
TABLE IV ______________________________________ (PHASE II) ______________________________________Pigs 1 and 2: Negative stimulation to one wound (128 pps, 35 ma) No Stimulation to second wound (control). Pig 3: Two control wounds, no stimulation.4, 5, 6: Negative stimulation to one wound (128 pps, 35 ma) for three days followed by positive stimulation (128 pps, 35 ma) for three days. No stimulation to second wound (control). ______________________________________ All stimulation was for onehalf hour per wound, twice a day, separated by an interval of at least four hours. Note: For the purposes of the following statistical reporting, the contro wound and the 35 ma stimulation wound from phase one is included as it represents identical treatment of identical wounds. This pig is referred henceforth as Pigs pig 0.
TABLE V ______________________________________ WOUND AREA (cms.sup.2) CONTROLSWks Dys Pig 0Pig 1Pig 2 Pig 3RPig 3L Pig 5Pig 6 ______________________________________ 0 1 27.29 30.00 42.20 44.45 47.47 47.62 2 44.23 1 7 51.69 38.43 8 37.65 45.13 32.50 2 14 38.93 39.50 7.93 14.58 15 30.21 8.26 25.24 3 20 21.99 28.00 3.99 4.14 1.76 21 19.00 23 1.81 25 2.03 2.77 4 28 10.58 31 1.55 1.87 0.76 1.21 34 5.86 6.00 40 5.86 ______________________________________
TABLE VI ______________________________________ WOUND AREA (cms.sup.2) STIMULATED WOUNDS Negative Stim. Only Negative/Positive Stim.Wks Days Pig 0Pig 1Pig 2Pig 4Pig 5Pig 6 ______________________________________ 0 1 36.66 45.50 49.59 46.58 53.83 2 43.17 1 7 47.76 30.15 8 34.01 43.23 52.00 10 18.85 2 14 42.30 44.00 7.21 9.44 15 29.81 6.99 3 20 31.96 28.00 4.3 21 19.20 23 0.69 1.44 4 28 15.57 11.00 31 0.00 0.33 34 6.70 6.00 40 6.02 ______________________________________
TABLE VII ______________________________________ WOUND AREA (cms.sup.2) STATISTICAL SUMMARY CONTROL NEG. STIM. POS/NEG STIM. Time (n = 7) (n = 3) (n = 3) ______________________________________ 0 40.47 ± 8.33 41.78 ± 4.58 48.09 ± 2.13 1 week 41.08 ± 7.44 43.08 ± 9.00 30.15(n = 1) (n = 5) 2 weeks 23.52 ± 13.52 38.70 ± 7.75 7.88 ± 1.36 3 weeks 11.53 ± 11.09 23.05 ± 12.16 2.14 ± 1.91 4 weeks 3.19 ± 4.15 13.29 ± 3.23 0.17 ± 0.23(n = 3) (n = 5) ______________________________________ All values are expressed as means ± standard deviation.
TABLE VIII ______________________________________ Effect of Pulsed Electrical Stimulation of Epidermal Wound Healing (two animals)Treatment Day 2Day 3Day 4Day 5Day 6Day 7 ______________________________________ Animal-Pig 7 Active 0/12** 0/10** 0/10** 0/12** 5/11** 11/11** Machines (0%) (0%) (0%) (8%) (45%) (100%) 1-A,B,C Animal- Pig 8Sham 0/11** 0/12** 0/9** 0/12** 4/10** 11/11** Machines* (0%) (0%) (0%) (0%) (40%) (100%) 2-A,B,C ______________________________________ *Treatment pads were negative on0, 2, 4, 6 and positive on day 1, 3 4 and 7. **Data is presented as number of wounds healed per number of wounds assessed. () Percent of wounds healed. days
TABLE IX ______________________________________ HT.sub.50 and Relative Rate of Healing of Wounds Treated with Pulsed Electrical Stimulation Relative Rate Treatment HT.sub.50 # of Healing ______________________________________ Animal -Pig 7 Active Machines 6.1 +2 1-A,B,C* Animal - Pig 8 Sham Machines 6.2 2-A,B,C ______________________________________ #The time taken for 50% of the wounds to reepithelize. *Treatment pads were negative on0, 2, 4, 6 and postive on days 1, 3 5 and 7. Relative Rate of Healing ##STR1## - The animal that was treated with machines 1-A,B,C, initiated re-epithelization one day earlier than the animal which received treatment with the sham machines (2-A,B,C,). days
TABLE X ______________________________________ Effect of Pulsed Electrical Stimulation on Epidermal Wound Healing (one animal)Treatment Day 2Day 3Day 4Day 5 ______________________________________ Animal - Pig 9 Active Machines* 0/12** 0/10** 6/6** 8/8** 1-A,B,C (0%) (0%) (100%) (100%) ______________________________________ *Treatment pads were negative onday 0 and positive on days 1-7. **Data is presented as number of wounds healed per number of wounds evaluated. () Percent of wounds healed.
TABLE XI ______________________________________ HT.sub.50 and Relative Rate of Healing of Wounds Treated with Pulsed Electrical Stimulation Relative Rate Treatment HT.sub.50 # of Healing ______________________________________ Animal - Pig 9 Active Machines* 3.5 +44% 1-A,B,C Sham Machines* 6.2 2-A,B,C ______________________________________ *Treatment pads were negative onday 0 and positive on days 1-7. Relative Rate of Healing =- ##STR2## The time taken for 50% of the wounds to reepithelize.
TABLE XII ______________________________________ Effect of Pulsed Electrical Stimulation on Epidermal Wound Healing (one animal)Treatment Day 2Day 3Day 4Day 5Day 6Day 7 ______________________________________ Animal-Pig 10 Active 0/5** 0/5** 0/5** 0/5** 3/5** 3/5** Machine (0%) (0%) (0%) (0%) (60%) (100%) 1-A*Sham 0/5 0/5 0/5 0/5 5/5 Machine (0%) (0%) (0%) (0%) (100%) 2-A* ______________________________________ *Treatment pads were negative onday 0 and positive on days 1-7. **Data is presented as number of wounds healed per number of wounds assessed. () Percent of wounds healed.
TABLE XIII ______________________________________ HT.sub.50 and Relative Rate of Healing of Wounds Treated with Pulsed Electrical Stimulation Relative Rate Treatment HT.sub.50 # of Healing ______________________________________ Animal -Pig 10 Active Machine 5.8 -5.4% 1-A Sham Machine 5.5 -- 2-A ______________________________________ #The time taken for 50% of the wound to reepithelize. *Relative Rate of Healing =- ##STR3## - The electrically stimulated wounds had a relative rate of healing -5.4 when compared to sham control on the same animal. The reason that no differences were observed when electrical stimulation was delivered using one active machine and one sham machine to different wounds on the same animal is unknown, but is believed to illustrate a systemic effect. After reviewing our findings, the protocol inExperiment 2 was used to complete more animals for a full study of the effects of electrical stimulation.
TABLE XIV ______________________________________ Effect of Pulsed Electrical Stimulation on Epidermal Wound Healing (combined data: three additional animals plus animal used inExperiment 2 and sham animal from Experiment 1)Treatment Day 2Day 3Day 4Day 5Day 6Day 7 ______________________________________ Active 0/48** 7/44** 27/39** 26/36** 36/36** -- Machines* (0%) (16%) (69%) (74%) (100%) -- 1-A,B,C Sham 0/37 0/38 10/33 23/35 24/30 33/33 Machines* (0%) (0%) (30%) (66%) (80%) (100%) 2-A,B,C ______________________________________ *Treatment pads were negative onday 0 and positive days 1-7. **Data is presented as number of wounds healed per number of wounds assessed. () Percent of wounds healed.
TABLE XV ______________________________________ HT.sub.50 and Relative Rate of Healing of Wounds Treated with Pulsed Electrical Stimulation Relative Rate Treatment HT.sub.50 # of Healing ______________________________________ Active Machines* 3.8 +17% 1-A,B,C Sham Machines* 4.6 -- 2-A,B,C ______________________________________ *Treatment pads were negative onday 0 and positive on days 1-7. #The time taken for 50% of the wounds to reepithelize. Relative Rate of Healing =- ##STR4##
TABLE XVI ______________________________________ Tissue necrosis in the mid-region of bipedicled skin flaps Control Untreated Sham-treated Electrical Treatment ______________________________________ 27.1 ± 2.0 (12) 29.3 ± 3.3 (8) 13.2 ± 2.3 (28)* ______________________________________ Tissue necrosis is expressed as a percent of flap area. Each figure represents a mean ± S.E.M., with the number of flaps in parentheses. *p < 0.001 vs. either untreated or shamtreated control.
TABLE XVII ______________________________________ Alteration of tissue metabolites in skin flaps following electrical stimulation Post-operative days 0 3 6 14 ______________________________________ Glucose Control 10.3 ± 1.26 (5) 1.08 (2) 11.8 (2) 6.8 (2) EC-treated 2.80 (2) 11.2 (2) 8.1 (2) Lactate Control 8.8 ± 0.76 (7) 20.7 (2) 14.1 (2) 11.5 (2) EC-treated 18.1 (2) 16.9 (2) 13.5 (2) Lactate/Glucose Control 0.85 ± 0.05 (5) 19.1 (2) 1.19 (2) 2.34 (2) EC-treated 9.9 (2) 1.51 (2) 1.67 (2) ATP Control 1.57 ± 0.14 (5) 0.38 (2) 0.48 (2) 1.74 (2) EC-treated 0.36 (2) 1.03 (2) 2.24 (2) Malondialdehyde Control 63.3 ± 7.8 (3) 226 (2) 181 (2) 52 (2) EC-treated 150 (2) 173 (2) 114 (2) RNA Control 2.29 ± 0.77 (6) 3.16 (2) 2.57 (2) -- EC-treated 3.63 (2) 2.10 (2) -- DNA Control 3.61 ± 0.75 (6) 5.89 (2) 4.71 (2) -- EC-treated 4.55 (2) 6.52 (2) -- RNA/DNA ratio Control 0.79 ± 0.11 (6) 0.52 (2) 0.56 (2) -- EC-treated 0.85 (2) 0.37 (2) -- ______________________________________ Tissue contents of glucose, lactate, and ATP are expressed as mmoles/kg dry weight, the content of malondialdehyde is umoles/kg dry weight, and the contents of RNA and DNA are g/kg dry weight. Each figure represents a mean ± S.E.M. with the number of skin flaps i parentheses.
TABLE XVIII ______________________________________ Dura- Actual S/S St. PtID Type tion Size______________________________________ Sham III 1 Decub. 182 6.00Sham II 2 Decub. 65 4.50Sham III 3 Decub. 8 12.25 (Surgical)Sham IV 4 Decub. 304 5.25Sham IV 5 Decub. 23 7.50 (Vascular)Sham III 6 Decub. 4 12.25Sham III 7 Decub. Unk. 30.00 Sham IV 8 Decub. Unk. 12.25 Sham III 9 Decub. 60 6.40Sham II 10 Decub. 2190 74.70 (Surgical) Sham III 11 Decub. 7 67.50 (Surgical) Sham IV 12 Decub. 730 8.40Sham III 13 Decub. 224 5.10 Sham III 14 Decub. 365 5.55Sham III 15 Decub. 90 20.40 Sham IV 16 Decub. 90 40.00 Sham III 17 Decub. 517 5.28 (Vascular) Sham III 18 Decub. 70 4.05Sham III 19 Decub. 182 6.76Sham III 20 Decub. 1095 41.48Sham IV 21 Neuro/Vas 182 15.19 Sham III 22 Vascular 486 21.50 Sham III 23 Vascular 182 10.23Sham III 24 Vascular 730 40.00 Sham III 25 Vascular 2204 49.00 Sham IV 26 Vascular 173 49.00 Sham IV 27 Vascular 1226 5.88 Sham III 28 Vascular 1537 26.60 Sham IV 29 Vascular 1095 28.91Sham IV 30 Vascular 5615 7.60 Sham III 31 Vascular 730 20.35 Stim. III 32 Decub. 77 5.00 Stim. IV 33 Decub. 19 15.64 Stim. IV 34 Decub. 182 21.50 Stim. III 35 Decub. 26 44.00 (Surgical) Stim. III 36 Decub. 8 8.64 (Surgical) Stim. III 37 Decub. 117 6.00 Stim. III 38 Decub. 60 38.63 Stim. III 39 Decub. 27 7.00 (Trauma) Stim.III 40 Decub. 2 5.85 (Other) Stim. III 41 Decub. 6 9.89 (Surgical) Stim. III 42 Decub. 6 4.00 Stim. III 43 Decub. 79 4.60 (Surgical) Stim. III 44 Decub. Unk. 12.50 Stim. III 45 Decub. 175 4.80 Stim. III 46 Decub. 14 40.50 Stim. IV 47 Decub. 241 9.28 (Vascular) Stim. III 48 Decub. 72 16.25 (Surgical) Stim. III 49 Decub. 90 4.95 Stim.III 50 Decub. 30 8.00 Stim. III 51 Decub. 231 9.00 Stim. III 52 Decub. Unk. 22.80 Stim. III 53 Decub. 189 21.00 Stim. III 54 Decub. 7 17.39 (Surgical) Stim. III 55 Burn 259 9.02 Stim. IV 56 Neuro 42 4.92 Stim. III 57 Neuro. 60 5.25 Stim. IV 58 Vascular 31 16.56 Stim. III 59 Vascular 730 59.20 Stim.III 60 Vascular 409 40.32 (Surgical) Stim. IV 61 Vascular 365 42.12 Stim. IV 62 Vascular 4745 8.55 Stim. III 63 Vascular 140 33.21 Stim. III 64 Vascular 1460 4.00 Stim. III 65 Vascular 28 5.10 Stim. III 66 Vascular 182 12.50 Stim. III 67 Vascular 587 20.90 Sham III 68 Decub. 34 12.00 delete Sham II 69 Decub. Unk. 11.60 deleteSham II 70 Decub. Unk. 3.84 delete Sham III 71 Decub. Unk. 3.60 delete Sham IV 72 Vascular 2555 0.48 delete Sham IV 73 Vascular 2555 0.96 delete Sham IV 74 Vascular 2555 0.06 delete Sham III 75 Vascular 7300 2.45 delete Sham III 76 Vascular 1623 3.10 delete Sham III 77 Vascular 7300 1.36 delete Sham IV 78 Vascular 2555 1.80 delete Sham II 79 Vascular 730 285.60 delete Stim.III 80 Decub. 44 5.50 delete Stim. III 81 Decub. 1128 30.15 delete Stim. IV 82 Decub. 304 9.38 delete Stim. III 83 Decub. Unk. 2.10 delete Stim. III 84 Decub. 51 41.25 delete Stim. IV 85 Decub. Unk. 17.10 delete Stim. III 86 Decub. 200 5.40 delete Stim. IV 87 Decub. 72 20.25 delete Stim. III 88 Decub. 168 1.32 (Surgicdelete) Stim. III 89 Decub. 118 3.84 delete Stim.III 90 Vascular 5475 8.16 (Vasculdelete) Stim. III 91 Vascular 193 96.00 delete Stim. III 92 Vascular 2232 46.25 delete Stim. IV 93 Vascular 201 45.50 delete Stim. III 94 Vascular 486 23.32 delete Stim. II 95 Vascular 1825 77.00 delete Stim. IV 96 Vascular 319 19.76 delete Stim. III 97 Vascular 1460 162.00 delete ______________________________________ PtID Week 2 Week 4 Week 6 Week 8 ______________________________________ 1 62.50 90.00 2 11.11 7.78 3 45.71 5.31 4 178.57 178.57 5 66.67 21.33 8.00 6 17.96 83.59 7 40.83 108.33 8 222.69 139.59 9 26.56 0.00 10 96.72 81.39 11 57.04 6.40 12 72.38 31.25 13 117.65 37.65 14 97.29 100.90 15 80.88 66.18 16 60.00 28.12 17 79.55 51.52 18 72.59 65.68 19 107.84 142.01 20 85.34 90.89 21 128.40 133.33 22 100.00 100.00 23 69.89 51.32 24 82.50 64.60 25 19.31 97.04 26 105.80 92.86 27 63.78 37.41 28 77.59 58.80 44.25 29 94.29 89.66 30 133.42 102.24 31 408.16 184.77 32 75.00 72.00 85.00 42.00 33 35.17 10.55 1.60 34 88.88 92.09 87.91 78.14 35 75.00 39.45 19.09 5.09 36 81.48 6.94 37 30.00 4.17 0.00 38 23.30 1.29 0.21 0.08 39 91.07 75.00 60.00 42.86 40 85.47 68.38 41 54.60 0.40 42 28.00 21.00 3.00 43 33.91 48.04 44 112.00 70.56 43.20 13.20 45 54.17 15.63 31.25 12.50 46 90.25 66.44 35.85 25.93 47 96.98 90.95 48 40.62 4.62 0.37 49 24.24 34.14 50 80.00 75.00 57.50 50.00 51 35.56 18.33 52 105.61 62.72 53 77.38 49.71 44.52 38.67 54 60.72 19.84 55 81.49 33.15 56 31.71 173.98 57 92.57 112.76 58 95.95 65.40 34.78 16.67 59 70.95 175.91 60 72.92 46.88 21.60 14.43 61 76.92 73.72 62 95.91 81.52 72.98 63 104.88 105.96 64 9.00 30.00 65 105.88 90.00 66 96.00 51.52 32.40 37.60 67 88.76 80.96 80.96 68 350.00 0.00 0.00 0.00 69 112.07 0.00 0.00 0.00 70 106.25 0.00 0.00 0.00 71 119.44 58.33 72 160.42 75.00 0.00 0.00 73 100.00 57.29 0.00 74 200.00 0.00 0.00 0.00 75 100.00 204.08 269.39 76 435.48 100.65 77 100.00 112.50 88.24 78 102.78 50.56 79 105.28 83.49 80 101.82 0.00 0.00 81 114.63 91.94 134.66 127.20 82 53.33 32.00 83 90.00 95.24 84 26.67 15.44 12.73 4.41 85 110.29 78.60 86 64.81 66.67 16.30 38.70 87 149.38 88 96.97 98.48 71.59 89 125.00 287.50 90 54.41 91 86.94 0.00 0.00 0.00 92 121.10 133.81 173.79 204.04 93 100.00 140.66 94 100.00 92.20 81.82 95 89.62 0.00 0.00 0.00 96 92.31 0.00 0.00 0.00 97 91.39 89.63 98.67 ______________________________________
TABLE XIX ______________________________________ Group Size 4-Week# Statistics Mean S.D. Mean S.D. N ______________________________________ Sham Decub. 18.78 20.70 66.82 49.62 20 Stim. Decub. 14.66 11.70 41.18 30.43 23 Sham Vascular 25.91 15.19 87.87 38.89 10 Stim. Vascular 26.25 17.64 80.19 38.26 10 Sham "Other" 15.19 0.00 133.33 .00 1 Stim. "Other" 6.40 1.86 106.63 57.66 3 ______________________________________ *Normalized Percent
TABLE XX ______________________________________ Group Size 4-Week# Statistics Mean S.D. Mean S.D. N ______________________________________ All Sham 20.96 19.05 75.76 47.77 31 All Stim. 16.63 14.19 57.47 42.30 36 ______________________________________ *Normalized Percent
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